Ensure that both research ethics and the Human Tissue Act designated individual (DI), Dr Penny Lympany. are informed about your project/collection.
No Material Transfer Agreement will be signed without ethics registration or favourable ethics opinion from SGREC or NHS REC.
When you need to register your project
- Research project with human tissue from an HTA-licensed Biobank with generic ethical approval for use of the tissue in research
- Research limited to secondary use of tissue samples previously collected, in the course of normal care in UK, with consent for research and the patients or service users are not identifiable to the research team
What you need to submit to register your project
- Study protocol: what samples are collected or stored; where will the samples be stored; if the samples are anonymised or are identifiable; what research is planned; what will happen if any are left after the research; what HTA training the researcher has received
- Material Transfer Agreement (MTA) if applicable
- Favourable ethics opinion and study protocol (translated to English where applicable) or evidence of generic approval (Biobank)
If research involves the use and storage of human tissue (relevant material), ethical approval and R&D registration must be obtained to ensure that your work complies with the Human Tissue Act 2004.
For information regarding the documentation process of human tissue at SGUL please go to the relevant section.
Research on human tissue samples requires ethical approval and requires the participant’s consent.
When ethical opinion can be obtained from SGREC
- Research involving volunteers who are not NHS patients, including NHS staff
- The material has been transferred to SGUL from outside of the organisation (UK or outside of UK) for the purposes of research without valid research ethics opinion
- Access to human tissue from a HTA-licensed Biobank without ethical approval for use in research
Any tissue approved for such studies must be stored in an HTA-licenced premise.
When ethics opinion from an NHS REC and HRA is required
- Research involving participants who are NHS patients, collection of tissue from NHS patients
- The use of previously collected tissue from which past or present NHS patients could be identified
- To store or use the tissue of a living or deceased person for a research project on premises without a licence from the HTA
- To store or use tissue from the living for a research project without consent where the samples are anonymised to the researcher
- To analyse human DNA in material from the body of a living person (or using the results of DNA analysis) without consent, in circumstances where the researcher is unable to identify the tissue donor and not likely to be able to do so in the future
- To store or use tissue for a research project where consent is required and the tissue is from adults unable to consent for themselves
- To export tissue from the living and there is no consent in place for use in future research
All staff working with human tissue under the University's Research Licence and those who may wish to retain tissue at the end of an ethically approved research project must comply with
- HTA Codes of Practice
- University policies and procedures for the management of human tissue samples for research
- Undertake the MRC human tissue e-learning training, once you are on the page choose Research and Human Tissue Legislation - updated.